ReviewDigital biomarkers
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint.
Review in Digital biomarkers. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The use of digital outcome measures in clinical trials in rare neurological diseases: a systematic literature review.Orphanet journal of rare diseases · 2023Pooled it
- Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review.Journal of medical Internet research · 2022Pooled it
- Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways.Clinical pharmacology and therapeutics · 2026Review
- Home-based eye tracking for early autism screening: a scoping review of approaches, evidence, and implementation challenges.BMC psychiatry · 2026Article
- Equity and Transportability of Plasma ATN Phenotypes in a Population-Representative U.S. Aging Cohort.medRxiv : the preprint server for health sciences · 2026Article
- Using wearable and nearable devices in telerehabilitation for COPD: a scoping review of digital endpoints in home-based programs.Frontiers in digital health · 2026Review
- Automatic speech analysis combined with machine learning reliably predicts the motor state in people with Parkinson's disease.NPJ Parkinson's disease · 2025Article
- V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.NPJ digital medicine · 2025Review
- Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event.Trials · 2024Article
- Do Measures of Real-World Physical Behavior Provide Insights Into the Well-Being and Physical Function of Cancer Survivors? Cross-Sectional Analysis.JMIR cancer · 2024Article
- A coating machine for coating filaments with bioactive nanomaterials for extrusion 3D printing.Heliyon · 2024Article
- From wearable sensor data to digital biomarker development: ten lessons learned and a framework proposal.NPJ digital medicine · 2024Review
- Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance.NPJ digital medicine · 2024Review
- Improved measurement of disease progression in people living with early Parkinson's disease using digital health technologies.Communications medicine · 2024Article
- An automatic measure for speech intelligibility in dysarthrias-validation across multiple languages and neurological disorders.Frontiers in digital health · 2024Article
- Measuring What Is Meaningful in Cancer Cachexia Clinical Trials: A Path Forward With Digital Measures of Real-World Physical Behavior.JCO clinical cancer informatics · 2023Review
- 3D Video Tracking Technology in the Assessment of Orofacial Impairments in Neurological Disease: Clinical Validation.Journal of speech, language, and hearing research : JSLHR · 2023Article
- Digital therapeutics in the clinic.Bioengineering & translational medicine · 2023Review
- Editorial: Multimodal digital approaches to personalized medicine.Frontiers in big data · 2023Article
- Capturing Measures That Matter: The Potential Value of Digital Measures of Physical Behavior for Alzheimer's Disease Drug Development.Journal of Alzheimer's disease : JAD · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.